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510(k) K133811

RESTORIS POROUS PARTIAL KNEE SYSTEM by Mako Surgical Corp. — Product Code NJD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2014
Date Received
December 16, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Device Class
Class II
Regulation Number
888.3535
Review Panel
OR
Submission Type

Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.

Other clearances by Mako Surgical Corp.

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  • K250608 — Mako Total Knee Application (3.0); Hybrid Tip Pointer (April 25, 2025)
  • K243751 — Mako Total Hip Application 5.0 (March 5, 2025)
  • K242373 — Mako Shoulder Application (1.0) (November 7, 2024)
  • K241011 — Mako Total Knee Application (June 11, 2024)
  • K220930 — Restoris Multi-Compartmental Knee System (June 2, 2022)
  • K220459 — Mako Total Knee Application (April 15, 2022)
  • K193515 — Mako Total Knee Application (July 14, 2020)
  • K193128 — Mako Total Hip Application (February 2, 2020)
  • K191998 — Mako Total Hip Application, Mako Total Knee Application (September 24, 2019)

Other clearances for product code NJD

  • K251975 — Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component (September 2, 2025)
  • K242307 — ACHIEVE Partial Knee System (December 16, 2024)
  • K222653 — JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System (October 28, 2022)
  • K190439 — Engage™ Partial Knee System (November 21, 2019)